Study of Nab-paclitaxel in Sensitive and Refractory Relapsed SCLC
NCT03219762 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65
Last updated 2017-07-26
Summary
Evaluate the activity and safety of Nab-paclitaxel in patients with sensitive or refractory SCLC who relapsed after cisplatin or carboplatin and etoposide first-line chemotherapy.
Conditions
Interventions
- DRUG
-
Nabpaclitaxel
Chemotherapy will be continued until a maximum of 6 courses or progressive disease or intolerable toxicity or patient refusal. In patients with confirmed and prolonged disease response, clinical benefit and good tolerance to study drug treatment, the investigators can evaluate to continue therapy beyond 6th cycle, after discussion with Principal Investigator (PI) of the study
Sponsors & Collaborators
-
Temas srl
collaborator UNKNOWN -
Clirest s.r.l.
collaborator OTHER -
Mipharm S.p.A.
collaborator UNKNOWN -
Istituto Toscano Tumori
collaborator OTHER -
Gruppo Oncologico Italiano di Ricerca Clinica
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-02-07
- Primary Completion
- 2019-01-31
- Completion
- 2019-01-31
- FDA Drug
- Yes
Countries
- Italy
Study Locations
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